PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02730312 |
Recruitment Status :
Recruiting
First Posted : April 6, 2016
Last Update Posted : March 15, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myelogenous Leukemia B-cell Acute Lymphoblastic Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm Chronic Myeloid Leukemia, Blast Crisis | Biological: XmAb14045 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies |
Actual Study Start Date : | August 2016 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | August 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: XmAb14045
Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
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Biological: XmAb14045
Administered IV weekly up to 8 weeks, with or without induction dosing |
- Safety as determined by the number of participants with treatment-related adverse events [ Time Frame: Baseline Day 1 through Day 56 ]Treatment-related adverse events as assessed by CTCAE v4.03
- Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing [ Time Frame: Baseline Day 1 through Day 56 ]Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Diagnosis of 1 of the following diseases:
- Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
- B-cell ALL
- BPDCN
- CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
- Patients with relapsed or refractory disease with no available standard therapy
- ECOG performance status 0-2
- Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
- Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
- Able and willing to complete the entire study
Exclusion Criteria:
- Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
- Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
- Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
- Known uncontrolled central nervous system involvement by malignant disease
- Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
- Diagnosis of promyelocytic leukemia
- Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement
- Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
- Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min
- History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation
- Evidence of any active, uncontrolled bacterial, viral, parasitic fungal infections within 1 week of first dose of study drug
- Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
- Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730312
Contact: Wayne Saville, MD | 858-633-6632 | wsaville@xencor.com | |
Contact: Chelsea Johnson, RN | 858-480-3891 | cjohnson@xencor.com |
United States, Florida | |
Mayo Clinic Jacksonville Florida | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Carol Fairchild, RN Fairchild.carol@mayo.edu | |
United States, Georgia | |
Northside Hospital | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Stacey Brown 404-851-8238 Stacey.brown@northside.com | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Wendy Stock, MD wstock@medicine.bsd.uchicago.edu | |
Contact: Kristy Johnson 773-702-4936 kjohnson@medicine.bsd.uchicago.edu | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Kasturi Ganesh Barki 614-685-6227 kasturi.ganesh@osumc.edu | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Farhad Ravandi-Kashani, MD 713-745-0394 fravandi@mdanderson.org | |
United States, Washington | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Raya Mawad, MD | |
Contact: Tenzin Tsomo 206-386-2831 Tenzin.Tsomo@swedish.org |
Study Director: | Wayne Saville, MD | VP, Oncology Clinical Development, Xencor, Inc. |
Responsible Party: | Xencor, Inc. |
ClinicalTrials.gov Identifier: | NCT02730312 History of Changes |
Other Study ID Numbers: |
XmAb14045-01 |
First Posted: | April 6, 2016 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Xencor, Inc.:
AML B-ALL BPDCN CML Blast Crisis |
Additional relevant MeSH terms:
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Acute Burkitt Lymphoma Blast Crisis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders |
Bone Marrow Diseases Hematologic Diseases Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma Cell Transformation, Neoplastic Carcinogenesis Neoplastic Processes Pathologic Processes |